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Monday, 01/09/2006 8:41:09 AM

Monday, January 09, 2006 8:41:09 AM

Post# of 253178
GTC Biotherapeutics Receives Notice of Allowance on Transgenic Production Patent
Monday January 9, 8:38 am ET

http://biz.yahoo.com/bwml/060109/95518.html?.v=1

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Jan. 9, 2006--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for the claims in its patent application 07/938,322 covering the production of therapeutic proteins in the milk of transgenic mammals. The allowed claims, which are expected to issue in the next several weeks, include all classes of proteins in all mammals and will provide GTC with a strong intellectual property position regarding the development and use of this technology for US markets. The patent that is expected to issue from this application will not expire until 2021.
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"GTC has an extensive intellectual property portfolio for the production of therapeutic proteins in milk and we will continue to use our broad IP position to encourage the adoption of transgenic production technology by our collaborators and partners," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "This broad patent will provide long term protection for GTC's proprietary products in the USA, including our lead program for ATryn®."

GTC's lead program is ATryn®, its recombinant form of human antithrombin. A Market Authorization Application is under review by the European Medicines Agency for the use of ATryn® in patients with a hereditary antithrombin deficiency. ATryn® is also in a pivotal phase III study for the prevention of thromboembolic events in patients with hereditary antithrombin deficiency who are undergoing high-risk procedures, such as surgery or childbirth. GTC anticipates using the results from this clinical study to prepare a Biologics License Application for the United States Food and Drug Administration.

Antithrombin is a protein in human plasma that has anticoagulant and anti-inflammatory properties.

GTC is able to produce a therapeutic protein in an animal's milk through a process known as transgenic technology. GTC couples the gene expressing a specific protein with a specific milk protein promoter gene and incorporates it into an animal's genome such that the protein is expressed during lactation. This approach enables the production of therapeutic proteins that are difficult to express through traditional production methods. For those products that can be expressed with conventional recombinant technologies, transgenic technology has significantly lower capital requirements to establish large volume capacity.

About GTC Biotherapeutics, Inc.
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